HomeSwitzerlandYPSOMED AG

YPSOMED AG

Switzerland · Burgdorf
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 0Class II 5Class III 0
plus 7 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
11 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Business type not stated 1Import 2
AUAustraliaTGA ARTG
8active ARTG entries
Class I 1IIa 4IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
6active registrations
Class 1 3Class 2a 3
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 12 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: YPSOMED AG

Company information

Country
Switzerland
City
Burgdorf

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22010
12012
32013
22015
12016
22017
12025

FDA listed device types

Introducer, Syringe Needle 1Injection Data Capture Device 1Pump, Infusion, Insulin 1Injector, Pen 1Set, Administration, Intravascular 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243901SmartPilot YpsoMate NS-A2.252025-08-28
USK171984Clickfine Pen Needle, Penfine Classic Pen Needle2017-10-11
USK163400Orbit Inserter2017-07-26
BR82702499001Terrosa® PenClass II
CA102656YPSOMED APPClass II

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